Anti-mullerian Hormone (AMH) Measured as a Continuous Variable, Specifically Assessing the Intra-person Change From Study Entry (Day 0) to 6-month Post-intervention Visit
| Group | Value (ng/ml) | Spread |
|---|---|---|
| LUPRON | 2.07 | 1.92 |
| Placebo | 3.87 | 4.00 |
Trial · Interventional
TerminatedPhase 3Results postedRegistry dataShort name LUPRON
This trial was stopped early.
The registry gives no reason.
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study it to determine whether the use of a gonadotropin releasing hormone (GnRH)-agonist (depot-leuprolide acetate) during cyclophosphamide (CYC) therapy in women with rheumatic diseases will provide greater ovarian protection than placebo.
Active comparator
LUPRON
Monthly depot leuprolide acetate 3.75 mg injection during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
Placebo comparator
Placebo
Monthly placebo injection during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses.
Outcomes the sponsor listed as primary.
Anti-mullerian Hormone (AMH) Measured as a Continuous Variable, Specifically Assessing the Intra-person Change From Study Entry (Day 0) to 6-month Post-intervention Visit
Time frame · Day 0 to 6-month post-intervention visit
AMH was quantified in vitro a commercially available enzyme linked immunosorbent assay (ELISA) (Beckman Coulter; Marseille, France) was used for in vitro quantitative measurement of serum AMH.
Count of Patients With AMH of ≤1.0 ng/mL vs >1 ng/mL,
Time frame · baseline and 6 months
AMH level ≤1.0 predicts onset of menopause within 5 years in normal women
Number of Participants With Either an AMH Level of >1 ng/mL OR Antral Follicle Count of >4.
Time frame · baseline and 6 months
An AMH level of \>1 ng/ml and/or an antral follicle count of \>4 in either ovary is a strong predictor of residual ovarian function
Mean Antral Follicle Count (AFC)
Time frame · baseline and 6 months
Mean antral follicle count (AFC) is the average number of follicles counted in each of 2 ovaries
Mean Ovarian Volume.
Time frame · baseline and 6 months
Mean ovarian volume reflects the preservation of ovarian tissue despite exposure to cyclophosphamide; reduced ovarian size is documented in cyclophosphamide treated patients
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (ng/ml) | Spread |
|---|---|---|
| LUPRON | 2.07 | 1.92 |
| Placebo | 3.87 | 4.00 |
| Group | Value (Participants) |
|---|---|
| LUPRON | 3 |
| PLACEBO | 6 |
| Group | Value (Participants) |
|---|---|
| LUPRON | 4 |
| PLACEBO | 6 |
| Group | Value (# of ovarian follicles) | Spread |
|---|---|---|
| LUPRON | 10.3 | 9.29 |
| PLACEBO | 14.4 | 12.4 |
| Group | Value (cubic centimeters) | Spread |
|---|---|---|
| LUPRON | 9.59 | 2.69 |
| PLACEBO | 7.68 | 3.50 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| LUPRONdepot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses | 0 / 6 | 1 / 6 | 5 / 6 |
| Placebodepot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses | 0 / 8 | 1 / 8 | 5 / 8 |
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